Study Results
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Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2021-03-15
2023-12-01
Brief Summary
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The investigators will conduct a randomized clinical trial with three arms to investigate if micellar cassein isolate and whey protein supplementation as part of a high-protein diet during 4 weeks of weight maintenance and 20 weeks of hypocaloric intake (30% energy restriction) inducing modest weight loss (5% of baseline weight) has beneficial effects on NAFLD severity and metabolic aberrations compared to normal diet in NAFLD patients.
It is hypothesized that: (i) a high-protein diet improves liver disease severity and metabolic function compared to a normal protein diet; (ii) Cassein provides greater benefits than whey; and(iii) these effects manifest during both weight maintenance and weight loss.
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Detailed Description
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All subjects will be phone-contacted on a regular basis by study personnel to monitor progress, resolve problems with the diets, and reinforce compliance; and meet in person with the study dietitians weekly during the weight maintenance phase and biweekly during the weight loss phase to have their body weight measured and receive dietary counselling. Before study initiation, the research teams will put together standardized procedures for patient contact and nutrition counselling, including creating nutrition information leaflets specific to each randomization arm, to ensure uniformity between the study centers. In practice, dietary guidance will be tailored to the individual patient to ensure weight maintenance within 2% of baseline body weight during the first phase (weight stability), and a weight loss of 0.25% per week to reach the target 5% weight loss after 20 weeks during the second phase (weight loss); energy intake will be adjusted as necessary by adding or removing carbohydrate to meet the desired goals. Three-day diet records will be collected before and every 2 weeks during the interventions to evaluate energy and macronutrient intakes. A 3-hour urine sample will be collected during the mixed meal test at baseline, after 4 and 24 weeks in order to monitor dietary protein intake. Participants will be instructed in how to do the sampling and storing the sample cool during the collection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Micellar Cassein Isolate High-Protein Diet
4weeks eucaloric intake on high-protein diet with micellar cassein as primary protein source followed by 20weeks hypocaloric intake on equivalent protein rich diet.
High-Protein Diet
Diet consisting of 25E% from assigned protein during eucaloric diet and 35E% from assigned protein during hypocaloric diet
Clinical dietician
Counselling from a clinical dietician bi-weekly until weight loss of 5% is achieved.
Weight loss
4 weeks eucaloric diet \~13 MJ/day followed by, 20 weeks hypocaloric diet \~9 MJ/day until 5% weight loss is achieved.
Whey Protein High-Protein Diet
4weeks eucaloric intake on high-protein diet with whey protein as primary protein source followed by 20weeks hypocaloric intake on equivalent protein rich diet.
High-Protein Diet
Diet consisting of 25E% from assigned protein during eucaloric diet and 35E% from assigned protein during hypocaloric diet
Clinical dietician
Counselling from a clinical dietician bi-weekly until weight loss of 5% is achieved.
Weight loss
4 weeks eucaloric diet \~13 MJ/day followed by, 20 weeks hypocaloric diet \~9 MJ/day until 5% weight loss is achieved.
Normal Diet
4weeks eucaloric diet with normal protein content (15E%) followed by 20weeks hypocaloric intake on equivalent diet.
Clinical dietician
Counselling from a clinical dietician bi-weekly until weight loss of 5% is achieved.
Weight loss
4 weeks eucaloric diet \~13 MJ/day followed by, 20 weeks hypocaloric diet \~9 MJ/day until 5% weight loss is achieved.
Interventions
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High-Protein Diet
Diet consisting of 25E% from assigned protein during eucaloric diet and 35E% from assigned protein during hypocaloric diet
Clinical dietician
Counselling from a clinical dietician bi-weekly until weight loss of 5% is achieved.
Weight loss
4 weeks eucaloric diet \~13 MJ/day followed by, 20 weeks hypocaloric diet \~9 MJ/day until 5% weight loss is achieved.
Eligibility Criteria
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Inclusion Criteria
* HbA1C \< 48 mmol/mol
* Written informed consent
* Liver steatosis \> 10% on MR-spectroscopy
* Premenopausal women will have a negative pregnancy test drawn within 48 hours before the study.
Exclusion Criteria
* Known systemic disease exempting hypertension and dyslipidemia.
* Former or active malignant disease
* Alcohol consumption \>2 drinks/day for men, 1 drink/day for women, evaluated by AUDIT-C
* Pregnancy
* Any medications including non-prescription medications exempting, birth control medications, antihypertensives and statins. Participants taking statins can participate on the condition of a 2 week pause before the experimental days.
* Estimated glomerular filtration rate \<90 ml/min
* Currently smoking
* Blood donation within the last 3 months
* Weight above 130 kg
* Participated in trials using radioactive isotopes within the last 6 months
25 Years
70 Years
ALL
No
Sponsors
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Arla Foods
INDUSTRY
University of Copenhagen
OTHER
Hvidovre University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Henning Grønbæk, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Aarhus University Hospital, Dept. Hepatology and Gastroenterology
Aarhus N, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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DAIPRO-NAFLD
Identifier Type: -
Identifier Source: org_study_id
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